BEUDAMED
    FDA Enforcement Class II Terminated

    Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012

    Recall: Z-0800-2013 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0800-2013
    Event ID
    63433
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bacterin International, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 20, 2013
    Initiation Date
    April 18, 2012
    Classification Date
    February 11, 2013
    Termination Date
    May 13, 2013
    Address
    600 Cruiser Ln, Belgrade, MT, 59714-9719, United States

    Description

    Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012

    Reason

    Expired product was shipped to two customers.

    Code Info

    Graft ID# B090056-664 and Graft ID#: B090056-675, both with Donor# B090056 and Expiration Date: 12/25/2011. A thrid graft with ID# B100078-908 expiration date 04/27/2012 was added to the recall 7/12/2012.

    Distribution

    Nationwide Distribution in TX , GA and CA.

    Quantity

    3 packages each containing 2.5cc of putty